Negative pressure wound therapy dressing recognition, wound status detection, and therapy adjustment

ABSTRACT

Negative pressure wound therapy systems, apparatuses, and methods for operating the systems and apparatuses are disclosed. In some cases, the system can include a dressing having electronic circuitry that wirelessly communicates a dressing identifier and/or other dressing information to a controller of a pump assembly of the system. The controller can automatically modify one or more operational parameters of the pump assembly based on the dressing identifier and/or other dressing information wirelessly communicated. Duration of time over which the dressing has been in use can be monitored and provision of therapy by the pump assembly can be disabled responsive to a determination that the duration of time has reached operational lifetime of the dressing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to United Kingdom Patent ApplicationNo. GB 1909551.2, filed on Jul. 3, 2019, and United Kingdom PatentApplication No. GB 1916553.9, filed on Nov. 14, 2019, the disclosure ofeach of which is incorporated by reference in its entirety.

FIELD

Aspects of the present disclosure relate to apparatuses, systems, andmethods for the treatment of wounds via negative pressure wound therapy.In some aspects, the present disclosure relates generally to reducinghuman error in the treatment of wounds with negative pressure woundtherapy.

BACKGROUND

Many different types of wound dressings are known for aiding in thehealing process of a human or animal. These different types of wounddressings include many different types of materials and layers, forexample, pads such as gauze pads or foam pads. Topical negative pressure(“TNP”) therapy, sometimes referred to as vacuum assisted closure,negative pressure wound therapy, or reduced pressure wound therapy, iswidely recognized as a beneficial mechanism for improving the healingrate of a wound. Such therapy is applicable to a broad range of woundssuch as incisional wounds, open wounds and abdominal wounds or the like.

TNP therapy assists in the closure and healing of wounds by reducingtissue edema; encouraging blood flow; stimulating the formation ofgranulation tissue; removing excess exudates, and may reduce bacterialload and thus reduce the potential for infection of the wound.Furthermore, TNP therapy permits less outside disturbance of the woundand promotes more rapid healing. A medical device (e.g., a TNP therapydevice) can include a user interface that allows a user to set orcontrol the operation of the medical device. The user interface can becomplex, making it difficult for a user to select the correct settingsfor the operation of the medical device as well as for determining ifTNP therapy is delivered correctly. A need exists for simplifying theprocess by which a user sets or controls the operation of a medicaldevice. A further need exists for reliable detection of the status ofTNP therapy.

SUMMARY

Embodiments of the present disclosure relate to apparatuses and methodsfor wound treatment. Some of the wound treatment apparatuses describedherein comprise a pump system or assembly for providing negativepressure to a wound site. The pump assembly can include a source ofnegative pressure. Wound treatment apparatuses may also comprise wounddressings that may be used in combination with the pump assembliesdescribed herein, and connectors for connecting the wound dressings tothe pump assemblies.

Some aspects of the present disclosure are directed to a negativepressure wound therapy system. A negative pressure wound therapy systemcan include a plurality of wound dressings configured to cover aplurality of wounds. The system can include a plurality of pressuresensors configured to be positioned in a plurality of fluid flow pathsfluidically connecting the plurality of wound dressings to a negativepressure wound therapy device. The negative pressure wound therapydevice can include a negative pressure source configured to befluidically connected to the plurality of wound dressings via theplurality of fluid flow paths. The negative pressure source can beconfigured to aspirate fluid from the plurality of wounds. The negativepressure wound therapy device can include a controller configured topair with the plurality of pressure sensors. The controller can beconfigured to provide a first indication of loss of negative pressure ina first wound of the plurality of wounds in response to a determinationthat a first pressure signal received from a first pressure sensorpositioned in a first fluid flow path fluidically connecting the firstwound to the negative pressure wound therapy device satisfies a firstpressure threshold indicative of a minimum negative pressure level atthe first wound.

The system of any of the preceding paragraphs and/or any of the systemsdisclosed herein can include one or more of the following features. Thesystem can include a plurality of conduits configured to fluidicallyconnect the plurality of wound dressings to the negative wound therapydevice. At least one or all pressure sensors of the plurality ofpressure sensors can be configured to be positioned on or within arespective conduit of the plurality of conduits. At least one or allconduits of the plurality of conduits can be made from substantiallynon-rigid material. The controller can be configured to provide a secondindication of loss of negative pressure in a second wound of theplurality of wounds in response to a determination that a secondpressure signal received from a second pressure sensor positioned in asecond fluid flow path fluidically connecting the second wound to thenegative pressure wound therapy device satisfies a second pressurethreshold indicative of minimum negative pressure level at the secondwound. The second wound can be different than the first wound. Thesecond indication can be different than the first indication. The firstand second pressure thresholds can be the same.

The system of any of the preceding paragraphs and/or any of the systemsdisclosed herein can include one or more of the following features. Oneor more of the first or second indications can include one or more of avisual alarm, audible alarm, tactile alarm, or communication of data toa remote computing device. The system can include a plurality ofindicators associated with the plurality of wounds. First indication caninclude activation of a first indicator of the plurality of indicatorsto indicate loss of negative pressure in the first wound. Firstindicator can be associated with the first wound. First indicator can bepositioned in a first conduit associated with the first wound dressing.First indicator can be configured to generate a visual indication. Firstindicator can be positioned at least partially within the first conduitand be at least partially covered by a substantially translucentmaterial. The indicators can be integrated into the pressure sensors.

The system of any of the preceding paragraphs and/or any of the systemsdisclosed herein can include one or more of the following features.Negative pressure wound therapy device can include an inlet in fluidiccommunication with the negative pressure source and an additionalpressure sensor configured to measure pressure in the inlet. The systemcan include a connector with a first branch configured to be connectedto the inlet and a plurality of second branches configured to beconnected to the plurality of fluid flow paths. At least one or allpressure sensors of the plurality of pressure sensors can be configuredto wirelessly communicate with the controller. At least one or allindicators if the plurality of indicators can be configured towirelessly communicate with the controller.

A negative pressure wound therapy system can include a wound dressing, apump assembly, and a conduit configured to fluidically connect the wounddressing to the pump assembly. The wound dressing can include a sensor.The pump assembly can include a controller and optionally an alarmsystem. The sensor can be configured to wirelessly communicate adressing identifier and/or other wound dressing information to thecontroller. The controller can be configured to automatically adjust oneor more operational parameters of the pump based on the dressingidentifier and/or the other wound dressing information wirelesslycommunicated.

The system of any of the preceding paragraphs and/or any of the systemsdisclosed herein can include one or more of the following features. Thesensor can be a pressure sensor. The controller can be configured toautomatically adjust an alarm threshold on the alarm system based on thedressing identifier and/or the other wound dressing informationwirelessly communicated. The sensor can be adapted to transmit atemperature reading to the controller. The dressing identifier and otherwound dressing information can inform the controller of at least one ofthe pieces of information selected from the group consisting of: a modeof operation of the pump, a size of the dressing, a leak rate of acontrolled leak path of the dressing, a contact layer type of thedressing, an optimum negative pressure to apply to the dressing. Thesensor can be adapted to inform the controller of a duration that thedressing has been active, or an average pressure, or a flow rate. Thedressing can include a controlled leak path. The controller can beconfigured to lockout operation of the pump assembly based on thedressing identifier and other wound dressing information and on whetherthe pump assembly detects a canister connected to the pump assembly. Thecontroller can be configured to lockout operation of the pump assemblybased on the dressing identifier and other wound dressing informationinforming the controller that the dressing has been in use for anintended duration of use.

Embodiments or arrangements of the present disclosure are described forillustrative purposes in the context of methods and systems for treatinga wound with topical negative pressure (TNP) therapy. However, thepresent disclosure is not limited to medical devices that are used forTNP therapy and can be applied to medical devices other than medicaldevices that are used for TNP therapy. The present disclosure can beimplemented, for example, in the context of blood glucose monitoringdevices, dialysis machines, or other medical devices.

A negative pressure wound therapy system can include at least one wounddressing configured to be positioned over a wound. The at least onewound dressing can include electronic circuitry. The system can includea negative pressure wound therapy device. The device can include anegative pressure source configured to provide negative pressure to thewound. The device can include a controller configured to operate thenegative pressure source. The electronic circuitry can be configured tomonitor a time duration during which the at least one wound dressing hasbeen in use and communicate to the controller dressing usageinformation. The controller can be configured to automatically adjustone or more operational parameters of the negative pressure woundtherapy device based the dressing usage information.

The system of any of the preceding paragraphs and/or any of the systemsdisclosed herein can include one or more of the following features. Thecontroller can be configured to, responsive to an indication from theelectronic circuitry that the time duration during which the at leastone wound dressing has been in use satisfies an operational lifetime ofthe at least one wound dressing, at least one of disable operation ofthe negative pressure source or provide a dressing change indication.The electronic circuitry can include a pressure sensor configured tomonitor pressure proximal to the wound. The electronic circuitry can beconfigured to initiate monitoring of the time duration during which theat least one wound dressing has been in use responsive to adetermination of at least one of initial activation of the negativepressure source or initial attainment of a threshold negative pressurelevel proximal to the wound. The determination of the initial attainmentof the threshold negative pressure level can be made based on one ormore readings of the pressure sensor. The electronic circuitry can beconfigured to pause monitoring the time duration during which the atleast one wound dressing has been in use responsive to receiving anindication from the controller that provision of negative pressure bythe negative pressure source has been interrupted. The electroniccircuitry can be configured to resume monitoring the time durationduring which the at least one wound dressing has been in use responsiveto receiving an indication from the controller that provision ofnegative pressure by the negative pressure source has been resumed.

The system of any of the preceding paragraphs and/or any of the systemsdisclosed herein can include one or more of the following features. Theelectronic circuitry can be configured to provide an indication of thetime duration during which the at least one wound dressing has been inuse. The indication can include at least one of auditory, visual, ortactile indication. The electronic circuitry is configured to providethe indication responsive to a determination that the time durationduring which the at least one wound dressing has been in use satisfies aduration threshold, the duration threshold being shorter than anoperational lifetime of the at least one wound dressing. The indicationcan be provided via at least one of the negative pressure wound therapydevice or the at least one wound dressing. The electronic circuitry canbe configured to communicate to the controller a dressing identifier.The dressing identifier can include at least one of: a mode of operationof the negative pressure source, a size of the at least one wounddressing, a leak rate of a controlled leak of the at least one wounddressing, a wound contact layer type of the at least one wound dressing,an optimum negative pressure to apply to the wound, or an operationallifetime of the at least one wound dressing. The electronic circuitrycan include memory configured to store the dressing identifier. Thecontroller can be configured to automatically adjust an alarm thresholdbased on the dressing identifier. The controller can be configured todisable operation of the negative pressure source based on at least oneof: the dressing identifier indicating canisterless operation andresponsive to a detection of a canister being fluidically connected tothe negative pressure source or the dressing identifier indicatingoperation with the canister and responsive to a detection of thecanister not being fluidically connected to the negative pressuresource.

The system of any of the preceding paragraphs and/or any of the systemsdisclosed herein can include one or more of the following features. Theelectronic circuitry can be configured to communicate to the controllerat least one of an average pressure or a flow rate. The controller canbe configured to automatically adjust the one or more operationalparameters of the negative pressure wound therapy device based on the atleast one of the average pressure or the flow rate. The electroniccircuitry can be configured to wirelessly communicate with thecontroller. The at least one wound dressing can include a plurality ofwound dressings. Each wound dressing of the plurality of wound dressingscan include the electronic circuitry. The controller can be configuredto at least one of: automatically adjust one or more operationalparameters of the negative pressure wound therapy device based on one ormore time durations during which the plurality of wound dressings havebeen in used or generate an indication responsive to a determinationthat therapy settings associated with at least some wound dressings ofthe plurality of wound dressings are incompatible.

A method of operating a negative pressure wound therapy system caninclude, by electronic circuitry of at least one wound dressingconfigured to be positioned over a wound and connected to a negativepressure source configured to provide negative pressure to the wound,monitoring a time duration during which the at least one wound dressinghas been in use and communicating dressing usage information to acontroller of a negative pressure wound therapy device. The method caninclude, by the controller of the negative pressure wound therapydevice, automatically adjusting one or more operational parameters of anegative pressure wound therapy device based the dressing usageinformation.

The method of any of the preceding paragraphs and/or any of the methodsdisclosed herein can include one or more of the following features. Themethod can include, by the controller, responsive to an indication fromthe electronic circuitry that the time duration during which the atleast one wound dressing has been in use satisfies an operationallifetime of the at least one wound dressing, performing at least one of:disabling operation of the negative pressure source or providing adressing change indication. The electronic circuitry can be configuredto monitor pressure proximal to the wound. The method can include, bythe electronic circuitry, initiating monitoring of the time durationduring which the at least one wound dressing has been in use responsiveto determining at least one of: initial activation of the negativepressure source or initial attainment of a threshold negative pressurelevel proximal to the wound. The method can include, by the electroniccircuitry, pausing monitoring the time duration during which the atleast one wound dressing has been in use responsive to receiving anindication from the controller that provision of negative pressure bythe negative pressure source has been interrupted. The method caninclude, by the electronic circuitry, resuming monitoring the timeduration during which the at least one wound dressing has been in useresponsive to receiving an indication from the controller that provisionof negative pressure by the negative pressure source has been resumed.

The method of any of the preceding paragraphs and/or any of the methodsdisclosed herein can include one or more of the following features. Themethod can include, by the electronic circuitry, providing an indicationof the time duration during which the at least one wound dressing hasbeen in use responsive to determining that the time duration duringwhich the at least one wound dressing has been in use satisfies aduration threshold, the duration threshold being shorter than anoperational lifetime of the at least one wound dressing. The at leastone wound dressing can include a plurality of wound dressings. Eachwound dressing of the plurality of wound dressings can include theelectronic circuitry. The method can include, by the controller,performing at least one of: automatically adjusting one or moreoperational parameters of the negative pressure wound therapy devicebased on one or more time durations during which the plurality of wounddressings have been in used or generating an indication responsive todetermining that therapy settings associated with at least some wounddressings of the plurality of wound dressings are incompatible.

Any of the features, components, or details of any of the arrangementsor embodiments disclosed in this application, including withoutlimitation any of the pump embodiments and any of the negative pressurewound therapy embodiments disclosed below, are interchangeablycombinable with any other features, components, or details of any of thearrangements or embodiments disclosed herein to form new arrangementsand embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure will now be described hereinafter,by way of example only, with reference to the accompanying drawings inwhich:

FIG. 1 illustrates a negative pressure wound therapy system.

FIGS. 2A and 2B illustrate a negative pressure wound therapy device andcanister.

FIG. 3 illustrates a schematic of a negative pressure wound therapydevice.

FIG. 4 illustrates a reduced pressure wound therapy system including apump assembly.

FIG. 5 illustrates a reduced pressure wound therapy system including apump assembly fluidically connected to multiple wounds.

DETAILED DESCRIPTION

Throughout this specification reference is made to a wound. The termwound is to be broadly construed and encompasses open and closed woundsin which skin is torn, cut or punctured or where trauma causes acontusion, or any other superficial or other conditions or imperfectionson the skin of a patient or otherwise that benefit from pressuretreatment. A wound is thus broadly defined as any damaged region oftissue where fluid may or may not be produced. Examples of such woundsinclude, but are not limited to, abdominal wounds or other large orincisional wounds, either as a result of surgery, trauma, sterniotomies,fasciotomies, or other conditions, dehisced wounds, acute wounds,chronic wounds, subacute and dehisced wounds, traumatic wounds, flapsand skin grafts, lacerations, abrasions, contusions, burns, diabeticulcers, pressure ulcers, stoma, surgical wounds, trauma and venousulcers or the like.

Embodiments or arrangements disclosed herein relate to methods andapparatuses for dressing and treating a wound with topical negativepressure (TNP) therapy. For example, but without limitation, anyembodiments disclosed herein may relate to treating a wound with reducedpressure (sometimes referred to as negative pressure) provided from apump kit. Although not required, any embodiments of the pump kit can besterile. As another non-limiting example, any embodiments disclosedherein relate to apparatuses and methods for controlling the operationof a TNP system. In some aspects, this disclosure generally relates tosystems, methods, and devices for activating or controlling a medicaldevice, in particular, for activating or controlling a pump assembly ofa negative pressure wound therapy system.

Some aspects of the present disclosure relate to systems and methods oftreating a wound with reduced pressure. Some aspects of the presentdisclosure are generally applicable to use in topical negative pressure(TNP) or reduced pressure therapy systems. Briefly, negative pressurewound therapy (NPWT) assists in the closure and healing of many forms of“hard to heal” wounds by reducing tissue edema, encouraging blood flowand granular tissue formation, or removing excess exudate and can reducebacterial load (and thus infection risk). In addition, the therapyallows for less disturbance of a wound leading to more rapid healing.TNP therapy systems can also assist in the healing of surgically closedwounds by removing fluid. In some embodiments, TNP therapy helps tostabilize the tissue in the apposed position of closure. A furtherbeneficial use of TNP therapy can be found in grafts and flaps whereremoval of excess fluid is important and close proximity of the graft totissue is required in order to ensure tissue viability.

As used herein, reduced or negative pressure levels, such as −X mmHg,represent pressure levels relative to normal ambient atmosphericpressure, which can correspond to 760 mmHg (or 1 atm, 29.93 inHg,101.325 kPa, 14.696 psi, etc.). Accordingly, a negative pressure valueof −X mmHg reflects pressure that is X mmHg below 760 mmHg or, in otherwords, a pressure of (760−X) mmHg. In addition, negative pressure thatis “less” or “smaller” than X mmHg corresponds to pressure that iscloser to atmospheric pressure (for example, −40 mmHg is less than −60mmHg). Negative pressure that is “more” or “greater” than −X mmHgcorresponds to pressure that is further from atmospheric pressure (forexample, −80 mmHg is more than −60 mmHg). In some cases, local ambientatmospheric pressure is used as a reference point, and such localatmospheric pressure may not necessarily be, for example, 760 mmHg.

Systems and methods disclosed herein can be used with other types oftreatment in addition to or instead of reduced pressure therapy, such asirrigation, ultrasound, heat or cold, neuro stimulation, or the like. Insome cases, disclosed systems and methods can be used for woundmonitoring without application of additional therapy. Systems andmethods disclosed herein can be used in conjunction with a dressing,including with compression dressing, reduced pressure dressing, or thelike.

Overview

A health care professional (HCP) can be presented with a bewilderingarray of dressings that can be used on wounds. Different dressing-typescan be better suited for different types of wounds and may requiredifferent operational parameters of the pump assembly that appliesnegative pressure to the wound. Correctly matching the operationalparameters of the pump assembly to the type of dressing that is attachedto the pump can allow optimal dressing performance and promote effectivenegative pressure wound therapy. Unless the HCP is a wound care expert,setting up the NPWT pump for optimal performance can involve someguesswork, or the pump may simply be left at the default settings. Thisis especially so if the operator is the patient, who will likely nothave had any wound care education.

In NPWT-patient settings, and in other patient-care settings as well,activation of an electrical medical device and prescription of a therapyregime delivered by the device can be complex for a user to set orprogram into the device. The device can have a user interface withmultiple options and indications for the user to select. For example, apump assembly of a NPWT system can allow a user to select multipletherapy options such as the wound pressure, the temporal variation ofwound pressure intensity, the volume of fluid infused into the wound,the pressure of the fluid infused into the wound, the time of therapy,and other operational parameters of the pump assembly. Medical devicesother than NPWT pump assemblies also have operational parameters thatare complex for a user to set or program into the device. For the sakeof clarity, the systems and methods of the present disclosure aredescribed herein often in terms of NPWT systems. However, the presentdisclosure is not limited to NPWT medical devices and can be applied tothe activation and operation of medical devices in general.

The NPWT systems of the present disclosure can link the dressing and thepump assembly such that the pump assembly is automatically informed ofthe optimal operational parameters to apply to the dressing. Thedressing can automatically inform a controller of the pump assembly oneor more pieces of information about the identity of the dressing that isattached to the pump assembly. The dressing can include a sensor (e.g.,pressure sensor) that wirelessly transmits data (e.g., dressinginformation) to a controller in the pump assembly. The controller canmodify the operational parameters of the pump assembly based on thedressing information received from the dressing such that the pumpassembly applies the appropriate operational parameters to the dressing.Such linking of the dressing to the pump assembly can be performedautomatically (for example, at initialization of therapy) and facilitatemore optimal treatment of the wound.

Wound Therapy System

FIG. 1 illustrates a negative pressure wound treatment system 100(sometimes referred to as a reduced pressure wound therapy system, a TNPsystem, or a wound treatment system) comprising a wound filler 130placed inside a wound cavity 110, the wound cavity 110 sealed by a woundcover 120. The wound filler 130 in combination with the wound cover 120can be referred to as a wound dressing. A conduit 140 (such as a singleor multi lumen tube) is connected the wound cover 120 with a woundtherapy device 150 (sometimes as a whole or partially referred to as a“pump assembly”) configured to supply reduced or negative pressure. Thewound cover 120 can be in fluidic communication with the wound cavity110.

With any of the systems disclosed herein, a wound therapy device can becanisterless (meaning that exudate is collected in the wound dressing oris transferred via the conduit 140 for collection to another location).However, any of the wound therapy devices disclosed herein can includeor support a canister.

Additionally, with any of the wound therapy systems disclosed herein,any of the wound therapy devices can be mounted to or supported by thewound dressing, or adjacent to the wound dressing. The wound filler 130can be any suitable type, such as hydrophilic or hydrophobic foam,gauze, inflatable bag, and so on. The wound filler 130 can beconformable to the wound cavity 110 such that it substantially fills thewound cavity 110. The wound cover 120 can provide a substantially fluidimpermeable seal over the wound cavity 110. In some cases, the woundcover 120 has a top side and a bottom side, and the bottom sideadhesively (or in any other suitable manner) seals with the wound cavity110. The conduit 140 or any other conduit disclosed herein can be formedfrom polyurethane, PVC, nylon, polyethylene, silicone, or any othersuitable material.

The wound cover 120 can have a port (not shown) configured to receive anend of the conduit 140. In some cases, the conduit 140 can otherwisepass through or under the wound cover 120 to supply reduced pressure tothe wound cavity 110 so as to maintain a desired level of reducedpressure in the wound cavity 110. The conduit 140 can be any suitablearticle configured to provide at least a substantially sealed fluid flowpathway or path between the wound therapy device 150 and the wound cover120, so as to supply the reduced pressure provided by the wound therapydevice 150 to wound cavity 110.

The wound cover 120 and the wound filler 130 can be provided as a singlearticle or an integrated single unit. In some cases, no wound filler isprovided and the wound cover by itself may be considered the wounddressing. The wound dressing may then be connected, via the conduit 140,to a source of negative pressure of the wound therapy device 150. Insome cases, though not required, the wound therapy device 150 can beminiaturized and portable, although larger conventional negativepressure sources (or pumps) can also be used.

The wound cover 120 can be located over a wound site to be treated. Thewound cover 120 can form a substantially sealed cavity or enclosure overthe wound site. The wound cover 120 can have a film having a high watervapour permeability to enable the evaporation of surplus fluid, and canhave a superabsorbing material contained therein to safely absorb woundexudate. In some cases, the components of the TNP systems describedherein can be particularly suited for incisional wounds that exude asmall amount of wound exudate.

The wound therapy system can operate with or without the use of anexudate canister. The wound therapy system can support an exudatecanister. In some cases, configuring the wound therapy device 150 andconduit 140 so that the conduit 140 can be quickly and easily removedfrom the wound therapy device 150 can facilitate or improve the processof wound dressing or pump changes, if necessary. Any of the pumpassemblies disclosed herein can have any suitable connection between theconduit 140 and the pump.

The wound therapy device 150 can deliver negative pressure ofapproximately −80 mmHg, or between about −20 mmHg and −200 mmHg. Notethat these pressures are relative to normal ambient atmospheric pressurethus, −200 mmHg would be about 560 mmHg in practical terms. In somecases, the pressure range can be between about −40 mmHg and −150 mmHg.Alternatively, a pressure range of up to −75 mmHg, up to −80 mmHg orover −80 mmHg can be used. Also in some cases a pressure range of below−75 mmHg can be used. Alternatively, a pressure range of overapproximately −100 mmHg, or even −150 mmHg, can be supplied by the woundtherapy device 150.

The wound therapy device 150 can provide continuous or intermittentnegative pressure therapy. Continuous therapy can be delivered at above0 mmHg, −25 mmHg, −40 mmHg, −50 mmHg, −60 mmHg, −70 mmHg, −80 mmHg, −90mmHg, −100 mmHg, −120 mmHg, −140 mmHg, −160 mmHg, −180 mmHg, −200 mmHg,or below −200 mmHg. Intermittent therapy can be delivered between lowand high negative pressure set points (sometimes referred to assetpoint). Low set point can be set at above 0 mmHg, −25 mmHg, −40 mmHg,−50 mmHg, −60 mmHg, −70 mmHg, −80 mmHg, −90 mmHg, −100 mmHg, −120 mmHg,−140 mmHg, −160 mmHg, −180 mmHg, or below −180 mmHg. High set point canbe set at above −25 mmHg, −40 mmHg, −50 mmHg, −60 mmHg, −70 mmHg, −80mmHg, −90 mmHg, −100 mmHg, −120 mmHg, −140 mmHg, −160 mmHg, −180 mmHg,−200 mmHg, or below −200 mmHg. During intermittent therapy, negativepressure at low set point can be delivered for a first time duration,and upon expiration of the first time duration, negative pressure athigh set point can be delivered for a second time duration. Uponexpiration of the second time duration, negative pressure at low setpoint can be delivered. The first and second time durations can be sameor different values.

In operation, the wound filler 130 can be inserted into the wound cavity110, and wound cover 120 can be placed so as to seal the wound cavity110. The wound therapy device 150 can provide negative pressure to thewound cover 120, which may be transmitted to the wound cavity 110 viathe wound filler 130. Fluid (such as, wound exudate) can be drawnthrough the conduit 140 and stored in a canister. In some cases, fluidis absorbed by the wound filler 130 or one or more absorbent layers (notshown).

Wound dressings that may be utilized with the pump assembly and systemsof the present application include Renasys-F, Renasys-G, Renasys AB, andPico Dressings available from Smith & Nephew. Further description ofsuch wound dressings and other components of a negative pressure woundtherapy system that may be used with the pump assembly and systems ofthe present application are found in U.S. Patent Publication Nos.2012/0116334, 2011/0213287, 2011/0282309, 2012/0136325 and U.S. Pat. No.9,084,845, each of which is incorporated by reference in its entirety.In some cases, other suitable wound dressings can be utilized.

FIGS. 2A and 2B illustrates a negative pressure wound therapy device 200(sometimes referred to as a wound therapy device) including a pumpassembly 230 and a canister 220. As illustrated, the pump assembly 230and the canister 220 can be connected, thereby forming the wound therapydevice 200. The pump assembly 230 can include one or more indicators,such as visual indicator 202 configured to indicate alarms and visualindicator 204 configured to indicate status of the pump assembly 230.The visual indicators 202 and 204 can alert a user (for example,patient, health care provider, or the like) to a variety of operating orfailure conditions of the pump assembly 230, including alerting the userto normal or proper operating conditions, pump failure, power suppliedto the pump or power failure, detection of a leak within the wound coveror flow pathway (sometimes referred to as fluid flow path), suctionblockage in the flow pathway, canister full, overpressure, or any othersimilar or suitable conditions or combinations thereof. Any one or moresuitable indicators can be additionally or alternatively used, such asvisual, audio, tactile indicator, and so on.

The pump assembly 230 can include a display 206 (such as a screen)mounted in a recess formed in a case of the pump assembly 230. Thedisplay 206 can be a touch screen display. The display 206 can supportplayback of audiovisual (AV) content, such as instructional videos, andrender a number of screens or graphical user interfaces (GUIs) forconfiguring, controlling, and monitoring the operation of the pumpassembly 230. The pump assembly 230 can include one or more strap mounts226 for connecting a carry strap to the pump assembly 230 or forattaching a cradle. The canister 220 may be replaced with anothercanister, such as when the canister 220 has been filled with fluid.

The pump assembly 230 can include buttons 212 (such as keys) that allowthe user to operate and monitor the operation of the pump assembly 230.One of the buttons 212 can operate as a power button to turn on/off thepump assembly 230. Another of the buttons 212 can operate as aplay/pause button for the delivery of therapy.

The canister 220 can hold fluid (such as, exudate) removed from thewound cavity 110. The canister 220 includes one or more latches forattaching the canister to the pump assembly 230. For example, thecanister 220 as illustrated can have a capacity of 300 mL and includegraduations. The canister 220 can include a tubing channel forconnecting to the conduit 140.

FIG. 2B illustrates a rear view 200B of the pump assembly 230 and thecanister 220. The pump assembly 230 can include a speaker 232 forproducing sound. The speaker 232 can generate an acoustic alarm inresponse to deviations in therapy delivery, non-compliance with therapydelivery, or any other similar or suitable conditions or combinationsthereof.

The pump assembly 230 can include a filter access door 234 for accessingand replacing one or more filters, such as antibacterial filters. Thepump assembly 230 can comprise a power jack 239 for charging andrecharging an internal battery of the pump assembly. The pump assembly230 can include a disposable power source, such as batteries, so that nopower jack is needed.

FIG. 3 illustrates a schematic of a control system 300 which can beemployed in the wound monitoring or treatment systems described herein,such as in the wound therapy device 200 of FIGS. 2A and 2B. Electricalcomponents can operate to accept user input, provide output to the user,operate the pressure source, provide network connectivity, and so on. Afirst processor can be responsible for user activity, and a secondprocessor can be responsible for controlling another device, such as apump 390.

Input and output to the other device, such as a pump 390, one or moresensors (for example, one or more pressure sensors 325 configured tomonitor pressure in one or more locations of the fluid flow path), orthe like, can be controlled by an input/output (I/O) module 320. Forexample, the I/O module can receive data from one or more sensorsthrough one or more ports, such as serial (for example, I2C), parallel,hybrid ports, and the like.

The processor 310 can receive data from and provide data to one or moreexpansion modules 360, such as one or more USB ports, SD ports, CompactDisc (CD) drives, DVD drives, FireWire ports, Thunderbolt ports, PCIExpress ports, and the like. The processor 310, along with othercontrollers or processors, can store data in memory 350 (such as one ormore memory modules), which can be internal or external to the processor310. Any suitable type of memory can be used, including volatile ornon-volatile memory, such as RAM, ROM, magnetic memory, solid-statememory, Magnetoresistive random-access memory (MRAM), and the like.

The processor 310 can be a general purpose controller, such as alow-power processor, or an application specific processor. The processor310 can be configured as a “central” processor in the electronicarchitecture of the control system 300, and the processor 310 cancoordinate the activity of other processors, such as a pump controlprocessor 370, communications processor 330, and one or more additionalprocessors 380. The processor 310 can run a suitable operating system,such as a Linux, Windows CE, VxWorks, etc.

The pump control processor 370 can control the operation of a pump 390,which can generate negative or reduced pressure. The pump 390 can be asuitable pump, such as a diaphragm pump, peristaltic pump, rotary pump,rotary vane pump, scroll pump, screw pump, liquid ring pump, diaphragmpump operated by a piezoelectric transducer, voice coil pump, and thelike. The pump control processor 370 can measure pressure in a fluidflow path, using data received from one or more pressure sensors 325,calculate the rate of fluid flow, and control the pump. The pump controlprocessor 370 can control the pump motor so that a desired level ofnegative pressure in achieved in the wound cavity 110. The desired levelof negative pressure can be pressure set or selected by the user. Thepump control processor 370 can control the pump (for example, pumpmotor) using pulse-width modulation (PWM). A control signal for drivingthe pump can be a 0-100% duty cycle PWM signal. The pump controlprocessor 370 can perform flow rate calculations and detect alarms. Thepump control processor 370 can communicate information to the processor310. The pump control processor 370 can be a low-power processor.

A communications processor 330 can provide wired or wirelessconnectivity. The communications processor 330 can utilize one or moretransceivers 340 for sending and receiving data. The one or moretransceivers 340 can include one or more antennas, optical sensors,optical transmitters, vibration motors or transducers, vibrationsensors, acoustic sensors, ultrasound sensors, or the like. Thecommunications processor 330 can provide one or more of the followingtypes of connections: Global Positioning System (GPS), cellularconnectivity (for example, 2G, 3G, LTE, 4G, 5G, or the like), near fieldcommunication (NFC), Bluetooth connectivity, radio frequencyidentification (RFID), wireless local area network (WLAN), wirelesspersonal area network (WPAN), WiFi connectivity, Internet connectivity,optical connectivity (for example, using infrared light, barcodes, suchas QR codes, etc.), acoustic connectivity, ultrasound connectivity, orthe like. Connectivity can be used for various activities, such as pumpassembly location tracking, asset tracking, compliance monitoring,remote selection, uploading of logs, alarms, and other operational data,and adjustment of therapy settings, upgrading of software or firmware,pairing, and the like.

The communications processor 330 can provide dual GPS/cellularfunctionality. Cellular functionality can, for example, be 3G, 4G, or 5Gfunctionality. The communications processor 330 can communicateinformation to the processor 310. The communications processor 330 caninclude internal memory or can utilize memory 350. The communicationsprocessor 330 can be a low-power processor.

The control system 300 can store data, such as GPS data, therapy data,device data, and event data. This data can be stored, for example, inmemory 350. This data can include patient data collected by one or moresensors. The control system 300 can track and log therapy and otheroperational data. Such data can be stored, for example, in the memory350.

Using the connectivity provided by the communications processor 330, thecontrol system 300 can upload any of the data stored, maintained, ortracked by the control system 300 to a remote computing device. Thecontrol system 300 can also download various operational data, such astherapy selection and parameters, firmware and software patches andupgrades, and the like. The one or more additional processors 380, suchas processor for controlling one or more user interfaces (such as, oneor more displays), can be utilized. In some cases, any of theillustrated or described components of the control system 300 can beomitted depending on an embodiment of a wound monitoring or treatmentsystem in which the control system 300 is used.

Any of the negative pressure wound therapy devices described herein caninclude one or more features disclosed in U.S. Pat. No. 9,737,649 orU.S. Patent Publication No. 2017/0216501, each of which is incorporatedby reference in its entirety.

Dressing Recognition and Therapy Adjustment

FIG. 4 illustrates a NPWT system 400, which can include one or morecomponents of any of the systems disclosed herein. For example, thesystem 400 can include one or more components of the device 200. Thesystem 400 can include one or more of: a fluidic connector 410, whichcan be a soft port (such as a Renasys Soft Port available from Smith &Nephew or a fluidic connector as described in U.S. Pat. No. 8,801,685,the entirety of which is hereby incorporated by reference), a controlledleak path (CLP) 420 provided at a proximal end or inlet (and/or anotherportion) of the fluidic connector 410, a controller 430 (which can besimilar to one more elements of the control system 300), a conduit 440connected to a proximal end of the fluidic connector 410, a negativepressure source 450, a pressure sensor 470 (which can be configured tomeasure pressure in an inlet of the negative pressure source 450), awound dressing 480, and electronic circuitry 490. The electroniccircuitry 490 can include one or more of: a controller, a sensor (forexample, dressing (or wound) pressure sensor configured to measurepressure at the wound), communication electronics configured to one ormore transmit to or receive data from the controller 430. Communicationelectronics can include a transceiver, as disclosed herein. Forinstance, communication electronics can be configured to communicatewirelessly, such as using Bluetooth, Zigbee, or the like. As anotherexample, communication electronics can be configured to communicate overa wired connection or over a connection that is both wired and wireless.The electronic circuitry 490 can be at least partially supported by(such as, embedded into) the wound dressing 480 and/or the fluidicconnector 410 (as illustrated, for example, in FIG. 5).

In some cases, as described herein, the canister 460 may not be present.The dressing 480 can be sealed over the wound 10. The conduit 440 canfluidically connect the negative pressure source 450 to the wound space(or volume) enclosed by the dressing 480. One or more of the negativepressure source 450, canister 460, conduit 440, CLP 420, fluidicconnector 410, or dressing 480 can form a fluid flow path via which thenegative pressure source 450 can aspirate fluid from the wound 10. Thenegative pressure source 450 can apply negative pressure to the wound 10through the conduit 440. As illustrated, the system 400 can include theexhaust 454 configured to expel gas aspirated by the negative pressuresource 450. The exhaust can include a one-way valve, such as anon-return valve, configured to permit fluid flow (for example, gasflow) in one direction. The controller 430 can control operation of thenegative pressure source. As disclosed herein (for instance, inconnection with FIGS. 2A-2B), one or more of the negative pressuresource 450, exhaust 454, load sensor 472, pressure sensor 470, andcontroller 430 can be supported by (such as, enclosed within) a housing,thereby forming a device or pump assembly.

The CLP 420 can provide a controlled flow of gas (such as, atmosphericair) to the wound 10 from the inlet of the fluid connector to thedressing. The load sensor 472 (e.g., tachometer) can monitor and informthe controller 430 of the performance (e.g., operating speed) of thenegative pressure source 450. The load sensor 472 can monitor activityof the negative pressure source 450. The CLP 420 can be used inconjunction with the conduit pressure sensor 470 and the load sensor 472to evaluate whether there is a blockage in the conduit 140 (and/or fluidflow path) or a leakage in the fluid flow path (such as, in the sealbetween the dressing 480 and the wound 10). For example, the load sensor472 can be a tachometer that informs the controller 430 of the operatingspeed of the negative pressure source 450.

The controller 430 can receive one or more pressure readings from theconduit pressure sensor 470 and evaluate whether the expected negativepressure supplied by the negative pressure source 450 operating at thespeed indicated by the tachometer matches the one or more pressurereadings from the conduit pressure sensor 470. In some arrangements, theCLP 420, the pressure in the conduit 440 (as measured by the conduitpressure sensor 470), and the operating performance on the negativepressure source 450 (as measured by the load sensor 472) can beinterpreted by the controller 430 to evaluate whether to signal analarm. The system can signal a leak alarm. The system can signal ablockage alarm. Any of the alarms or indications described herein caninclude one or more of visual, audible, tactile, or the likeindications. For instance, the controller 430 can be in communicationwith one or more indicators configured to provide indication(s). Inaddition to or alternatively, any of the alarms or indications describedherein can include transmission of information or data to a remotecomputing device.

The NPWT system 400 can have a wound pressure sensor and not a conduitpressure sensor 470 (or vice versa). The electronic circuitry canwirelessly (or via a wired connection) communicate to the controller 430wound pressure measured by the wound pressure sensor. The wound pressuresensor can be located within the wound space that is enclosed by thewound dressing 480. For example, the wound pressure sensor can be atleast partially supported by the dressing 480. In such arrangements, thewound pressure sensor can have the advantage of detecting the woundpressure directly. The wound pressure sensor can detect blockages in thefluid flow path (such as, at or in the fluidic connector 410) moreeasily and reliably than can the conduit pressure sensor 470. Forexample, the controller 430 can evaluate whether the wound pressure (asdetected by the wound pressure sensor) matches the expected woundpressure corresponding to the operating performance of the negativepressure source 450 (as detected from the load sensor 472), as discussedherein. In some cases, the wound pressure sensor can be positioned inthe port 410, as illustrated by 590A and 590B in FIG. 5.

One or more wound pressure sensors can allow the system 400 to morereliably treat two or more wounds. For example, two conduits 440connected to two separate dressings can each be connected to thenegative pressure source 450 through a Y-junction or Y-connector (see,for example, 555 in FIG. 5). Each of the two conduits 440 can delivernegative pressure from the negative pressure source 450 to a wound spaceenclosed by a dressing 480. A conduit pressure sensor 470 measuringpressure at the trunk of the Y-junction cannot determine as easily orreliably which, if any, of the two conduits 440 is blocked or which, ifany, of the two wound dressings 480 is leaking. By contrast, a woundpressure sensor disposed in each of the two dressings 480 canindependently evaluate the wound pressure at the corresponding wound 10.As will be appreciated, a wound pressure sensor located in the wound 10can avoid hydrostatic issues of the conduit 440, making the system 400more accurate and reliable for wounds at different heights andhydrostatic pressure heads. The wound pressure sensor can also avoidhaving to measure the wound pressure through an intervening canister460, as is the case of the conduit pressure sensor 470 disposed betweenthe canister 460 and the negative pressure source 450.

In addition to transmitting pressure information to the controller 430,the electronic circuitry 490 can wirelessly transmit dressinginformation to the controller 430 to inform the controller 430 aboutproperties of one or more of the dressing 480 that is connected to thenegative pressure source 450 or the wound 10. The wound pressure sensorcan be positioned at different locations within the dressing 480. Thewound pressure sensor can be disposed at any of the layers of thedressing 480 such as, for example, a wound contact layer, a wound fillerlayer, a foam layer, an absorbent layer, and a film layer. The woundpressure sensor can monitor one or more of dressing or wound operationalinformation such as temperature, which can be useful for monitoringtherapy, especially if the wound pressure sensor is located close to thewound 10 (e.g., at the wound contact layer). The electronic circuitry490 can include a memory storing the dressing information. The memorycan be read-only memory.

The dressing information transmitted to the controller 430 by theelectronic circuitry 490 can be an identifier that informs thecontroller 430 of the dressing type being used. Such identifier can beunique to each electronic circuitry 490. The identifier could includeparameterized information such as mode of operation (e.g., canister-modeor canisterless-mode), dressing size (e.g., area, capacity, or thelike), controlled leak rate (e.g., CLP operational parameters), woundcontact layer material (e.g., silicone), etc. The transmitted dressinginformation can provide functional information, such as the optimumnegative pressure to apply to the wound 10 and whether to apply negativepressure to the wound 10 in a continuous or discontinuous fashion.

Wound dressing 480 can be configured to be used for a limited durationof time (sometimes referred to as operational lifetime). At the end ofthe operational lifetime, the wound dressing 480 may need to bereplaced. For example, Pico dressing sold by Smith & Nephew can beconfigured to be worn for 7 days. As another example, Renasys-F foamdressing available from Smith & Nephew can be configured to be worn for3 days. As yet another example, Renasys-G gauze dressing available fromSmith & Nephew can be configured to be worn for 5 days. As yet furtherexample, Acticoat 3 antimicrobial dressing available from Smith & Nephewcan be configured to be worn for 3 days, and Acticoat 7 antimicrobialdressing available from Smith & Nephew can be configured to be worn for7 days. For efficacy of therapy and patient safety, it may beundesirable to exceed the operational lifetime of the dressing. Forexample, Pico dressing may become saturated with exudate, foam ofRenasys-F foam dressing may grow into the wound, or the like.

The dressing information can include operational lifetime of thedressing. Electronic circuitry 490 can monitor a duration of time duringwhich the dressing is in use. For example, electronic circuitry 490 canimplement a timer. In response to the duration of time satisfying (forexample, reaching) the operational lifetime, indication can becommunicated to the controller 430 to one or more of disable furtherprovision of negative pressure with that dressing or provide anindication that that dressing needs to be replaced. The controller 430can re-enable provision of negative pressure after the dressing has beenreplaced with a fresh dressing.

The controller 430 can determine that fresh dressing has been positionedover the wound based on unique dressing identifier transmitted by theelectronic circuitry 490, as described herein. Additionally oralternatively, the controller 430 can determine that fresh dressing hasbeen positioned over the wound based on the duration of time duringwhich the dressing has been in use. For instance, if the duration oftime communicated by the electronic circuitry 490 previously indicatedthat operational lifetime has been satisfied and presently the durationof time indicates that the dressing is at or near beginning of its use(such as, the duration being near or close to zero), the controller 430can determine that dressing had been replaced. Additionally oralternatively, a user can indicate that dressing has been replaced, suchthrough the user interface.

Electronic circuitry 490 can initiate monitoring the duration of time inresponse to activation of the negative pressure source 450, which cancause a pressure decrease to be sensed by the wound pressure sensor. Forexample, initial activation of the negative pressure source 450 cancause a pressure decrease that satisfies a pressure decrease thresholdassociated with initiating monitoring of the duration of time. Asanother example, electronic circuitry 490 can initiate monitoring of theduration of time in response to initial attainment of a negativepressure set point at the wound as sensed by the wound pressure sensor.Negative pressure set point can be included in the dressing information.Electronic circuitry 490 can continue monitoring the duration of timefollowing the initiation of monitoring irrespective of any interruptionsin the provision of NPWT.

In some cases, electronic circuitry 490 can pause monitoring theduration of time in response to interruption in the provision of therapy(or NPWT). Such pause can correspond to the time of therapyinterruption. The controller 430 can indicate to the electroniccircuitry 490 that therapy has been interrupted (and/or restarted).Alternatively or additionally, electronic circuitry 490 can determinethat therapy has been interrupted responsive to determining a pressureincrease (such as, a pressure increase or total pressure that satisfiesa pressure increase threshold). Alternatively or additionally, thecontroller 430 can monitor the duration of time and determine whether itsatisfies the operational lifetime.

An indication of the duration of time (or remaining period of time forwearing the dressing) can be provided by one or more of the electroniccircuitry 490 or controller 430. For example, indication can be providedbefore the operational lifetime has been reached (such as, 1 day beforeor the like). This could alert the user to an impending dressing change.Alternatively or additionally, indication can be provided in response toreaching the operational lifetime. Indication can be provided using anyof the approaches described herein, such as visually, audibly, and/ortactilely. The dressing 490 and/or the port 410 can include one or moreindicators for providing the indication.

In situations when multiple wounds are being treated by the system,wound dressings for each of the wounds can include the electroniccircuitry 490. Duration of time for each of the wound dressings can bemonitored individually.

The packaging of the dressing 480 can give clear information on thetypes of wounds for which the dressing 480 is suitable (e.g., ulcer,trauma, high exudate, etc.), and this information can be automaticallytransmitted to the controller 430 upon connection of the dressing 480 tothe negative pressure source 450. The information transmitted to thecontroller 430 by the electronic circuitry can be usage information(such as, operational lifetime of the dressing, how long the dressing480 has been in use (or active), etc.), average pressure(s), or flowrate(s). Electronic circuitry 490 can monitor average pressure based onthe readings of the wound pressure sensor. Averaging can facilitateremoval of one or more errant pressure readings. Errant readings may becaused by flow of lumps of fluid, solids, or the like. A flow sensor (orflow meter) can be positioned in the fluid flow path. For instance, flowsensor can be positioned in the port 410. Electronic circuitry 490 cantransmit flow information monitored by the flow sensor, for example, tothe controller 430. In some cases, flow information monitored by theflow sensor can be filtered (such as, averaged) to remove errant flowreadings. Flow information can be utilized to determine presence of leak(associated with high flow), blockage (associated with low flow), or thelike. Flow information can be advantageously utilized to determine stateof one of the wounds in a system treating a plurality of wounds, asdescribed herein. For instance, a higher flow rate may be associatedwith more exudate being aspirated, which can be indicative of infection.

In some cases, when the electronic circuitry 490 first pairs to thedevice (such as, to the controller 430), the electronic circuitry 490sends out the dressing identifier. Pairing can be performed via acommunication protocol, such as Bluetooth, Zigbee, or the like. Thedevice (such as, the controller 430) can use the dressing identifier toset up the preferred therapy mode for the dressing 480. In some cases,the preferred therapy mode is a canisterless mode in which exudate isabsorbed in the dressing. In some cases, the preferred therapy mode is acanister mode in which exudate is drawn into the canister 460.

In some cases, the dressing identifier can be used to disable or lockoutoperation of the negative pressure source 450. This can be performed,for example, if a canister 460 has been errantly connected to the NPWTsystem 400 and the dressing identifier indicates that the attacheddressing 480 is intended for use in a canisterless mode of operation ofthe device. In some cases, the dressing identifier can be used tolockout operation of the negative pressure source 450 if the canister460 has not been connected to the NPWT system 400 and the dressingidentifier indicates that the attached dressing 480 is intended for usein a canister mode of operation of the device.

The NPWT system 400 can automatically enable the preferred woundnegative pressure and the preferred continuous or discontinuous actionmode to be automatically set into the device (such as, by the controller430), thereby stopping any guesswork by the user. Additionally oralternatively, the alarms for the NPWT system 400 can be adjustedautomatically. For example, a leak threshold for an alarm could beraised for a dressing 480 with an expected larger leak rate (such as,due to size of the dressing, the built in CLP, or the wound contactlayer). A leak threshold for an alarm can be lowered for a dressing 480having a smaller expected leak rate. The system 400 can also adjustpressure alarms based on the preferred pressure setting dictated orindicated by the dressing 480.

The dressing 480 or the packaging for the dressing 480 can include acode (e.g., bar code, pin code, QR code, or the like) that is providedto the device (such as, to the controller 430) to inform about thedressing 480 that is connected to the negative pressure source 450. Insome cases, the code can be scanned by one or more sensors incommunication with the controller 430 (such as, one or more opticalsensors). In some cases, the transmission of the dressing identifier(for example, to the controller 430) can obviate the need for the userto enter a code or for the device to have additional components (e.g.,keypad, scanner) that add complexity.

Multiple Wound Operation and Status Detection

FIG. 5 illustrates a reduced pressure wound therapy system 500. Any ofthe components of the system 200 can function similarly to therespective components of the system 400. For example, a componentlabeled “5xx” (for example, “580A” or “580B”) of the system 500 canfunction similarly to a respective component “4xx” (for example, “480”)of the system 400. The system 500 can include a device or pump assembly550 fluidically connected to a plurality of wounds 10A and 10B coveredby wound dressings 580A and 580B. As described herein, the pump assembly550 can be fluidically connected to the plurality of wounds via aplurality of conduits 540A and 540B. A Y-connector 555 can connect thepump assembly 550 to the plurality of conduits 540A and 540B. Forexample, a first branch of the Y-connector 555 can be connected to aninlet of the pump assembly 550 and a plurality of second branches of theY-connector 555 can be connected to the plurality of conduits 540A and540B. The pump assembly 550 can include one or more of a pressure sensor(such as, the pressure sensor 470), load sensor (such as, the loadsensor 472), or controller (such as, the controller 430), as describedherein. In some cases, a canister (such as, the canister 460) can alsobe provided.

A fluid flow path fluidically connecting the pump assembly 550 to any ofthe wounds can include a fluidic connector, such as 510A and 510B, asillustrated in FIG. 5 and described herein. Any of the connectors can bea Renasys Soft Port available from Smith & Nephew. Any of the fluidicconnectors described herein can include or be made of non-rigid orsubstantially non-rigid material(s), such as the Renasys Soft Portconnector. As described herein, controlled leak paths (CLP) 520A and520B can be provided at a proximal end or inlet (and/or another portion)of any of the fluidic connectors, such as the connectors 510A or 510B.Any of the CLPs can admit gas (such as, atmospheric air) into arespective fluid flow path.

A plurality of electronic circuitries 590A and 590B are illustrated inFIG. 5. The electronic circuitries 590A and 590B can operate similarlyto the electronic circuitry 490 described herein. As described herein,the electronic circuitries 590A and 590B can each include a pressuresensor positioned in a respective fluid flow path. For example, asillustrated in FIG. 5, a pressure sensor can be positioned in each ofthe fluid flow path. The pressure sensor(s) can monitor pressure in thefluid flow path(s). In some cases, the pressure sensor(s) cancommunicate monitored pressure(s) to the controller of the pump assembly550. For example, one or more of the electronic circuitry(ies) canwirelessly or via a wired connection communicate measured pressure(s) tothe controller of the system 500. The pressure sensors of the electroniccircuities 590A and 590B can operate similarly to the pressure sensor ofthe electronic circuitry 490 described herein. For instance, thepressure sensors can measure pressure at or near the respective wound10A and 10B. In some cases, any of the pressure sensors can bepositioned on or in the respective fluidic connector, such as theconnector 510A or 510B. For example, any of the pressure sensors can bepositioned or embedded within a fluidic connector.

Pressure measured by any of the pressure sensors can be compared to apressure threshold indicative of a minimum level of negative pressurefor NPWT therapy. The pressure threshold can be about −60 mmHg or lessor more, about −40 mmHg or less or more, about −25 mmHg or less or more,about −20 mmHg or less or more, or the like. In some cases, the pressurethreshold can be dependent on a negative pressure setpoint of thenegative pressure source. For example, the pressure threshold can be setat a fixed or variable offset relative to the negative pressuresetpoint, such at about 10 mmHg or less or more, about 20 mmHg or lessor more, about 25 mmHg or less or more, or the like. For instance, ifthe negative pressure setpoint is −80 mmHg, the offset can be set at 20mmHg, which results in the pressure threshold of −60 mmHg. The offsetcan be variable, such as proportionally decreasing as the negativepressure setpoint decreases. For example, a first offset associated witha first negative pressure setpoint can be smaller than a second offsetassociated with a second negative pressure setpoint that is larger (ormore negative) than the first negative pressure setpoint.

In response to a determination that measured pressure satisfies thepressure threshold, it can be determined that there is loss of negativepressure in a particular fluid flow path (and/or wound) associated withthe pressure sensor, which can be indicative of inadequate applicationof NPWT therapy to the particular wound. Loss of pressure can be due toone or more of blockages, leaks, or the like in the fluid flow path.Such determination of loss of pressure can be made by the controller ofthe system 500. For example, in response to a determination thatpressure measured by the pressure sensor of the electronic circuitry590A meets or falls below the pressure threshold, it can be determinedthat there is loss of negative pressure at the wound 10A, which can beindicative of inadequate application of NPWT therapy to the wound 10B.Additionally or alternatively, in response to a determination thatpressure measured by the pressure sensor of the electronic circuitry590B meets or falls below the pressure threshold (or a differentpressure threshold), it can be determined that there is loss of negativepressure at the wound 10B, which is indicative of inadequate applicationof NPWT therapy to the wound 10B. In some cases, any one or more of thepressure sensors can be paired with the controller. This can allow thecontroller to identify for which of the fluid flow paths (and/or wounds)pressure measurements are being provided. Pairing and/or monitoring of awound can be performed, for example, via Bluetooth, Zigbee, or the like.In some cases, in addition to or instead of pairing, one or morepressure sensors can transmit an identifier configured to identifyassociated fluid flow path (and/or wound). For example, the identifiercan be a dressing identifier as described herein. The identifier can beunique to each of the pressure sensors (or electronic circuitries).

Indication or alarm can be provided in response to a determination ofloss or pressure in a particular fluid flow path (and/or wound).Indication can be provided by the controller. Indication can include anyone or more of visual, audible, tactile, or the like indications ortransmission of data to a remote computer. For instance, the pumpassembly 550 can include one or more indicators that can be activated(for example, by the controller) to provide one or more indications. Insome cases, indication can additionally or alternatively includemodification of operation of the negative pressure source, such asincrease in level of negative pressure provided by the negative pressuresource, pausing operation of the negative pressure source, or the like.Provision of indication(s) can cause a user (such as, HCP) to performone or more remedial actions with respect to provision of NPWT therapy,such as clearing a blockage (for example, by replacing a canister ordressing), fixing a leak in one or more fluid flow path(s), or the like.

In some cases, an indicator configured to provide any of the indicationscan be positioned in a fluid flow path. For example, an indicator can bepositioned in each of the fluid flow paths, such as embedded in afluidic connector and/or covered by a translucent material of thefluidic connector so that a visual indication can be provided to theuser. Any of the indicators can communicate with the controllerwirelessly or over a wired connection. The controller can activate anddeactivate any of the indicators.

In some instances, any of the pressure sensors can include one or moreindicators configured to provide any of the indications. For example, asdescribed herein, any of the pressure sensors can be embedded within afluidic connector. The pressure sensor can include a visual indicatorcovered by a translucent material of the fluidic connector so that avisual indication can be provided to the user. Any of the pressuresensors can detect loss of negative pressure and provide indicationwithout involvement of the controller. Any of the pressure sensors candetect loss of negative pressure and provide an indication of the lossof negative pressure to the controller, which in turn can provide one ormore indications to the user as described herein. For example, any ofthe pressure sensors can include a pressure switch configured togenerate an indication in response to monitored pressure satisfying thepressure threshold. Additionally or alternatively, the controller candetermine loss of negative pressure at one of the wounds and direct theassociated pressure sensor to generate the indication.

Dressing identifiers associated with at least some wound dressingcovering the wounds can indicate therapy settings that may beincompatible. For example, dressing identifier for a first wounddressing can indicate continuous provision of negative pressure by thenegative pressure source, while dressing identifier for a second wounddressing can indicate intermittent provision of negative pressure by thenegative pressure source. The controller can provide an indication inresponse to detecting incompatibility. The indication can be any of theindications disclosed herein. In some cases, the controller can beconfigured to resolve the incompatibility. In the above example, thecontroller could compromise between the two therapy settings byproviding intermittent negative pressure using negative pressure setpoints and/or time intervals that are different than those associatedwith the second wound dressing.

Advantageously, the system 500 can determine loss of pressure indicativeof insufficient application of NPWT therapy to a particular wound orwounds of a plurality of wounds. As described herein, remedial actioncan be taken by the user. This can prevent or limit interruptions ofNPWT therapy as such interruptions can compromise the healing process,cause wound maceration, or the like.

OTHER VARIATIONS

Although certain embodiments described herein relate to wound dressings,systems and methods for use with negative pressure wound therapy,approaches disclosed herein are not limited to negative pressure woundtherapy or medical applications. Systems and methods disclosed hereinare generally applicable for use with other therapies, includingultrasound, instillation, or the like, and to medical or electronicdevices in general, such as medical or electronic devices that can beworn by or applied to a user.

All of the features disclosed in this specification (including anyaccompanying exhibits, claims, abstract and drawings), and/or all of thesteps of any method or process so disclosed, may be combined in anycombination, except combinations where at least some of such featuresand/or steps are mutually exclusive. The disclosure is not restricted tothe details of any foregoing embodiments. The disclosure extends to anynovel one, or any novel combination, of the features disclosed in thisspecification (including any accompanying claims, abstract anddrawings), or to any novel one, or any novel combination, of the stepsof any method or process so disclosed.

Those skilled in the art will appreciate that in some embodiments, theactual steps taken in the processes illustrated or disclosed may differfrom those shown in the figures. Depending on the embodiment, certain ofthe steps described above may be removed, others may be added. Forexample, the actual steps or order of steps taken in the disclosedprocesses may differ from those shown in the figure. Depending on theembodiment, certain of the steps described above may be removed, othersmay be added. For instance, the various components illustrated in thefigures may be implemented as software or firmware on a processor,controller, ASIC, FPGA, or dedicated hardware. Hardware components, suchas processors, ASICs, FPGAs, and the like, can include logic circuitry.Furthermore, the features and attributes of the specific embodimentsdisclosed above may be combined in different ways to form additionalembodiments, all of which fall within the scope of the presentdisclosure.

Conditional language, such as “can,” “could,” “might,” or “may,” unlessspecifically stated otherwise, or otherwise understood within thecontext as used, is generally intended to convey that certainembodiments include, while other embodiments do not include, certainfeatures, elements, or steps. Thus, such conditional language is notgenerally intended to imply that features, elements, or steps are in anyway required for one or more embodiments or that one or more embodimentsnecessarily include logic for deciding, with or without user input orprompting, whether these features, elements, or steps are included orare to be performed in any particular embodiment. The terms“comprising,” “including,” “having,” and the like are synonymous and areused inclusively, in an open-ended fashion, and do not excludeadditional elements, features, acts, operations, and so forth. Also, theterm “or” is used in its inclusive sense (and not in its exclusivesense) so that when used, for example, to connect a list of elements,the term “or” means one, some, or all of the elements in the list.Likewise the term “and/or” in reference to a list of two or more items,covers all of the following interpretations of the word: any one of theitems in the list, all of the items in the list, and any combination ofthe items in the list. Further, the term “each,” as used herein, inaddition to having its ordinary meaning, can mean any subset of a set ofelements to which the term “each” is applied. Additionally, the words“herein,” “above,” “below,” and words of similar import, when used inthis application, refer to this application as a whole and not to anyparticular portions of this application.

Conjunctive language such as the phrase “at least one of X, Y, and Z,”unless specifically stated otherwise, is otherwise understood with thecontext as used in general to convey that an item, term, etc. may beeither X, Y, or Z. Thus, such conjunctive language is not generallyintended to imply that certain embodiments require the presence of atleast one of X, at least one of Y, and at least one of Z.

Language of degree used herein, such as the terms “approximately,”“about,” “generally,” and “substantially” as used herein represent avalue, amount, or characteristic close to the stated value, amount, orcharacteristic that still performs a desired function or achieves adesired result. For example, the terms “approximately”, “about”,“generally,” and “substantially” may refer to an amount that is withinless than 10% of, within less than 5% of, within less than 1% of, withinless than 0.1% of, and within less than 0.01% of the stated amount. Asanother example, in certain embodiments, the terms “generally parallel”and “substantially parallel” refer to a value, amount, or characteristicthat departs from exactly parallel by less than or equal to 15 degrees,10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degree.

Various modifications to the implementations described in thisdisclosure may be readily apparent to those skilled in the art, and thegeneric principles defined herein may be applied to otherimplementations without departing from the spirit or scope of thisdisclosure. Thus, the disclosure is not intended to be limited to theimplementations shown herein, but is to be accorded the widest scopeconsistent with the principles and features disclosed herein. Certainembodiments of the disclosure are encompassed in the claim set listedbelow or presented in the future.

What is claimed is:
 1. A negative pressure wound therapy system,comprising: at least one wound dressing configured to be positioned overa wound, the at least one wound dressing comprising an electroniccircuitry supported by the at least one wound dressing; and a negativepressure wound therapy device comprising: a negative pressure sourceconfigured to provide negative pressure to the wound via a fluid flowpath connecting the negative pressure source to the at least one wounddressing; and a controller configured to operate the negative pressuresource, wherein the electronic circuitry is configured to: monitor atime duration during which the at least one wound dressing has been inuse based on detecting an initial attainment of a negative pressure setpoint in the fluid flow path, and communicate to the controller adressing usage information, and communicate to the controller a dressingidentifier unique to the electronic circuitry that comprises a mode ofoperation of the at least one wound dressing with the negative pressurewound therapy device and the negative pressure set point, and whereinthe controller is configured to: automatically adjust one or moreoperational parameters of the negative pressure wound therapy devicebased on the dressing usage information, disable operation of thenegative pressure source responsive to a detection that 1) the dressingidentifier indicates canisterless operation and 2) a canister isfluidically connected to the negative pressure source, disable operationof the negative pressure source responsive to a detection that 1) thedressing identifier indicates operation with the canister and 2) thecanister is not fluidically connected to the negative pressure source,and responsive to an indication from the electronic circuitry that thetime duration during which the at least one wound dressing has been inuse satisfies an operational lifetime of the at least one wounddressing, disable operation of the negative pressure source and providea dressing change indication.
 2. The negative pressure wound therapysystem of claim 1, wherein the electronic circuitry comprises a pressuresensor configured to monitor pressure proximal to the wound.
 3. Thenegative pressure wound therapy system of claim 2, wherein theelectronic circuitry is configured to initiate monitoring of the timeduration during which the at least one wound dressing has been in useresponsive to a determination of initial attainment of the negativepressure set point in the fluid flow path, the determination of theinitial attainment being made based on one or more readings of thepressure sensor.
 4. The negative pressure wound therapy system of claim1, wherein the electronic circuitry is further configured to pausemonitoring the time duration during which the at least one wounddressing has been in use responsive to receiving an indication from thecontroller that provision of negative pressure by the negative pressuresource has been interrupted.
 5. The negative pressure wound therapysystem of claim 4, wherein the electronic circuitry is furtherconfigured to resume monitoring the time duration during which the atleast one wound dressing has been in use responsive to receiving anindication from the controller that provision of negative pressure bythe negative pressure source has been resumed.
 6. The negative pressurewound therapy system of claim 1, wherein the electronic circuitry isfurther configured to provide an indication of the time duration duringwhich the at least one wound dressing has been in use, the indicationcomprising at least one of auditory, visual, or tactile indication. 7.The negative pressure wound therapy system of claim 6, wherein theelectronic circuitry is configured to provide the indication responsiveto a determination that the time duration during which the at least onewound dressing has been in use satisfies a duration threshold, theduration threshold being shorter than the operational lifetime of the atleast one wound dressing.
 8. The negative pressure wound therapy systemof claim 6, wherein the indication is provided via at least one of thenegative pressure wound therapy device or the at least one wounddressing.
 9. The negative pressure wound therapy system of claim 1,wherein the dressing identifier further comprises at least one of: asize of the at least one wound dressing, a leak rate of a controlledleak of the at least one wound dressing, a wound contact layer type ofthe at least one wound dressing, or the operational lifetime of the atleast one wound dressing.
 10. The negative pressure wound therapy systemof claim 1, wherein the electronic circuitry comprises memory configuredto store the dressing identifier.
 11. The negative pressure woundtherapy system of claim 1, wherein the controller is further configuredto automatically adjust an alarm threshold based on the dressingidentifier.
 12. The negative pressure wound therapy system of claim 1,wherein the electronic circuitry is further configured to communicate tothe controller at least one of an average pressure or a flow rate, andwherein the controller is configured to automatically adjust the one ormore operational parameters of the negative pressure wound therapydevice further based on the at least one of the average pressure or theflow rate.
 13. The negative pressure wound therapy system of claim 1,wherein the electronic circuitry is configured to wirelessly communicatewith the controller.
 14. The negative pressure wound therapy system ofclaim 1, wherein: the at least one wound dressing comprises a pluralityof wound dressings, each wound dressing of the plurality of wounddressings comprising the electronic circuitry; and the controller isconfigured to at least one of: automatically adjust one or moreoperational parameters of the negative pressure wound therapy devicebased on one or more time durations during which the plurality of wounddressings have been in use or generate an indication responsive to adetermination that therapy settings associated with at least some wounddressings of the plurality of wound dressings are incompatible.
 15. Amethod of operating a negative pressure wound therapy system, the methodcomprising: by an electronic circuitry supported by at least one wounddressing, the at least one wound dressing configured to be positionedover a wound and connected by a fluid flow path to a negative pressuresource configured to provide negative pressure to the wound: monitoringa time duration during which the at least one wound dressing has been inuse based on detecting an initial attainment of a negative pressure setpoint in the fluid flow path, and communicating a dressing usageinformation to a controller of a negative pressure wound therapy deviceand communicating to the controller a dressing identifier unique to theelectronic circuitry that comprises a mode of operation of the at leastone wound dressing with the negative pressure wound therapy device andthe negative pressure set point; and by the controller of the negativepressure wound therapy device: automatically adjusting one or moreoperational parameters of a negative pressure wound therapy device basedon the dressing usage information, disabling operation of the negativepressure source responsive to detecting that 1) the dressing identifierindicates canisterless operation and 2) a canister is fluidicallyconnected to the negative pressure source, disabling operation of thenegative pressure source responsive to detecting that 1) the dressingidentifier indicates operation with the canister and 2) the canister isnot fluidically connected to the negative pressure source, andresponsive to an indication from the electronic circuitry that the timeduration during which the at least one wound dressing has been in usesatisfies an operational lifetime of the at least one wound dressing,disabling operation of the negative pressure source and providing adressing change indication.
 16. The method of claim 15, furthercomprising, by the electronic circuitry, pausing monitoring the timeduration during which the at least one wound dressing has been in useresponsive to receiving an indication from the controller that provisionof negative pressure by the negative pressure source has beeninterrupted.
 17. The method of claim 16, further comprising, by theelectronic circuitry, resuming monitoring the time duration during whichthe at least one wound dressing has been in use responsive to receivingan indication from the controller that provision of negative pressure bythe negative pressure source has been resumed.
 18. The method of claim15, further comprising, by the electronic circuitry, providing anindication of the time duration during which the at least one wounddressing has been in use responsive to determining that the timeduration during which the at least one wound dressing has been in usesatisfies a duration threshold, the duration threshold being shorterthan the operational lifetime of the at least one wound dressing. 19.The method of claim 15, wherein the at least one wound dressingcomprises a plurality of wound dressings, each wound dressing of theplurality of wound dressings comprising the electronic circuitry, andwherein the method further comprises: by the controller, performing atleast one of: automatically adjusting one or more operational parametersof the negative pressure wound therapy device based on one or more timedurations during which the plurality of wound dressings have been in useor generating an indication responsive to determining that therapysettings associated with at least some wound dressings of the pluralityof wound dressings are incompatible.
 20. The negative pressure woundtherapy system of claim 11, wherein the controller is further configuredto adjust a leak alarm threshold based on a leak rate of a controlledleak of the at least one wound dressing indicated by the dressingidentifier.
 21. The method of claim 15, further comprising, by thecontroller, adjusting a leak alarm threshold based on a leak rate of acontrolled leak of the at least one wound dressing indicated by thedressing identifier.